Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: Prevnar 13; Biological: Multivalent

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550313

C3571002

2020-005039-59 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).

Enrollment: 565 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
• Healthy infant determined by medical history, physical examination, and clinical judgment.

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
• Previous receipt of >1 dose of hepatitis B vaccine.
• Prior hepatitis B vaccine must have been administered at age <30 days.
• Major known congenital malformation or serious chronic disorder.
• Receipt of blood/plasma products or immunoglobulins.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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565 participants in 3 patient groups

Group 1 - Coadministration

Experimental group

Description:

Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13

Treatment:

Biological: Multivalent

Biological: Prevnar 13

Group 2 - Staggered Administration

Experimental group

Description:

Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13

Treatment:

Biological: Multivalent

Biological: Prevnar 13

Group 3 - Control with Supplemental Dose

Active Comparator group

Description:

Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine

Treatment:

Biological: Multivalent

Biological: Prevnar 13